BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 1022777 · Received March 28, 2008

    Report

    Report Number
    2955842-2008-00175
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Report Date
    March 28, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT ENGINEERING PLACED THE INSTRUMENT ON A DA VINCI S TEST SYS. SYS RECOGNITION PASSED. THE TEST SYS ALSO SHOWED ZERO USES REMAINING, INDICATING THAT THE INSTRUMENT HAD EXPIRED. ENGINEERING ALSO OBSERVED THE INSTRUMENT'S MAIN TUBE HAD A 6 INCH LONG SECTION, DIRECTLY ABOVE THE TUBE EXTENSION, MISSING MATERIAL AROUND ITS PERIMETER. WEAR PATTERN IS SIMILAR TO CANNULA RELATED TUBE ABRASIONS. NO OTHER DAMAGE FOUND. ADD'L INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A F/U MDR WILL BE SUBMITTED IF ADD'L INFO IS REC'D.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S RADICAL PROSTATECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT STOPPED WORKING. THE ACCOUNT ALSO INDICATED THAT THIS WAS THE THIRD PROCEDURAL USE OF THIS INSTRUMENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH ANOTHER INSTRUMENT. NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CURVED SCISSORS INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420179-08 1409071 141

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESSORIES| DA VINCI S SURGICAL SYS| ELECTROSURGICAL UNIT